FDA 510(k) Hematology Devices
About Hematology Devices
FDA 510(k) hematology devices include automated instruments used to analyze blood composition and coagulation. The FDA review panel code is HE.
Key device categories:
- Complete blood count (CBC) analyzers - automated cell counters for RBC, WBC and platelets
- Coagulation analyzers - PT/INR, aPTT, fibrinogen and factor assays
- Flow cytometry systems - immunophenotyping and cell sorting
- Blood typing and cross-match systems - transfusion medicine instruments
Most hematology devices are classified as Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.
3291
Total
3284
Cleared
113d
Avg days
1976
Since
97 Hematology devices
Cleared
Sep 13, 2017
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
GKA
Abnormal Hemoglobin Quantitation
100d
Cleared
Sep 08, 2017
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
LCO
Platelet Factor 4 Radioimmunoassay
170d
Cleared
Aug 22, 2017
i-STAT Hematocrit test with i-STAT Alinity System
JPI
Device, Hematocrit Measuring
266d
Cleared
Aug 11, 2017
ADVIA 2120i, ADVIA 2120
GKZ
Counter, Differential Cell
289d
Cleared
May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
KHE
Reagent, Occult Blood
265d
Cleared
Mar 03, 2017
ACL AcuStar
JPA
System, Multipurpose For In Vitro Coagulation Studies
30d
Cleared
Dec 22, 2016
Sysmex XN-L Automated Hematology Analyzer
GKZ
Counter, Differential Cell
300d
Cleared
Dec 22, 2016
XN CAL
KRX
Calibrator For Cell Indices
296d
Cleared
Dec 22, 2016
XN-L CHECK
JPK
Mixture, Hematology Quality Control
296d
Cleared
Dec 22, 2016
XN CHECK BF
JPK
Mixture, Hematology Quality Control
296d
Cleared
Dec 22, 2016
XN CHECK
JPK
Mixture, Hematology Quality Control
296d
Cleared
Nov 29, 2016
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
GKZ
Counter, Differential Cell
92d
Cleared
Oct 27, 2016
HemosIL D-Dimer HS
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
210d
Cleared
Sep 30, 2016
Xprecia Stride Coagulation System, Xprecia System PT Controls
GJS
Test, Time, Prothrombin
442d
Cleared
Sep 01, 2016
BC-5D Hematology Control
JPK
Mixture, Hematology Quality Control
183d
Cleared
Jul 08, 2016
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
LCO
Platelet Factor 4 Radioimmunoassay
252d
Cleared
Mar 16, 2016
HemosIL Silica Clotting Time
GFO
Activated Partial Thromboplastin
28d
Cleared
Mar 03, 2016
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
GKP
Instrument, Coagulation, Automated
30d
Cleared
Jan 31, 2016
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
GIS
Test, Fibrinogen
422d
Cleared
Dec 13, 2015
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
GKP
Instrument, Coagulation, Automated
256d
Cleared
Oct 12, 2015
XW-100 Automated Hematology Analyzer, XW QC CHECK
GKZ
Counter, Differential Cell
299d
Cleared
Jul 06, 2015
HemosIL D-Dimer HS
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
28d
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